A proper investigation is needed into why errors were made in the reading of the smear tests of the women affected by the CervicalCheck controversy, according to a solicitor representing many of the women.
Cian O’Carroll said no onsite audit had been carried out of the testing laboratories used to examine smears under the cervical cancer screening programme.
Neither has the option of bringing in the Health Information and Quality Authority (Hiqa) to investigate why so many smears which were originally classified as normal were found to have evidence of abnormal cells when they were audited later, after the women had been diagnosed with cancer, he said.
The case of Julie O’Reilly, the 60-year-old woman who died last month following a cervical cancer diagnosis, highlights the outstanding questions in the CervicalCheck controversy, he said.
As reported in The Irish Times on Saturday, evidence of pre-cancerous cells was missed in four consecutive smear tests Ms O’Reilly had under the programme between 2009 and 2013.
She was not told her slides had been audited, and their results revised, until this summer, after the CervicalCheck controversy became public when Vicky Phelan settled her High Court case against a testing lab for €2.5 million in April.
Ms O’Reilly’s husband Tony believes his wife might still be alive today “if they had picked up something back in 2009 and followed it through”.
Mr O’Carroll, who is representing Ms O’Reilly’s family, along with several dozen other CervicalCheck claims, alleged that the 60-year-old “lost her life as a result of the way these slides were read.
“It is alarming that an error of this nature could happen again and again. What are the chances laboratories would make the same mistake four times in a row?”
CervicalCheck, when it discovered the discordance between the original smear results and what was found in the audits, should have ensured each of these cases was recorded as an adverse event and followed up as a patient safety incident, he said.
False negatives – when abnormalities are present but not detected – are an inherent part of any screening programme, and do not necessarily mean negligence was involved.
Mr O’Carroll said issues to do with any alleged negligence could be settled by the courts, but there was still a need to ensure that errors were investigated and learned from when they occurred.
Formal complaint
Meanwhile, People Before Profit TD Bríd Smith has formally complained to Ceann Comhairle of the Dáil Seán Ó Fearghaíl over what she said was the refusal of the HSE and Minister for Health Simon Harris to answer a question on the CervicalCheck controversy.
The TD claimed that since May she had repeatedly asked the HSE to list the laboratories which read the slides of the more than 221 women caught up in the controversy. She says the question has never been answered, despite assurances from former HSE chief executive Tony O’Brien that it would be.
“It is utterly frustrating that each answer I have received has been full of obfuscation and waffle,” she said.
The TD said she was moved to complain formally after a PAC committee heard from HSE officials that since the Scally report on the controversy they had reviewed 221 cases.
Six months after the controversy first erupted, it remains unclear how many women are affected.
The HSE has so far written to 1,600 women with cervical cancer asking them for their consent for their slides to be reviewed by the Royal College of Obstetricians and Gynaecologists in the UK. However, only 32 per cent of those consent forms have been returned, with a majority agreeing to take part in the review.
Mr Harris is expected to face questions on the issue when he appears before the Oireachtas health committee on Wednesday.